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Field of Effects of Two Commercial Preparations of Botulinum Toxin Type A

This study has been completed.
Sponsor:
Information provided by:
Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier:
NCT00989768
First received: October 5, 2009
Last updated: May 24, 2010
Last verified: October 2009
History of Changes
  Purpose

The objective of this study is to compare the field of effects of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more detailed data on the effectiveness in reduction of wrinkles and duration of action on the upper part of the face of both products, trough scales and photographs evaluations.


Condition Intervention Phase
Wrinkles in Frontal Area
 Drug: Botulinum Toxin Type A (Dysport®)
Drug: Botulinum Toxin Type A/Botox®
Drug: Botulinum Toxin Type A/Dysport®
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Field Effects of Two Commercial Preparations of Botulinum Toxin Type a Administered to the Frontalis Muscles

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Brazilan Center for Studies in Dermatology:

Primary Outcome Measures:
  • Horizontal Action Halo Diameter at 28 Days [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    The colorful complex formed by Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 28 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).

  • Horizontal Action Halo Diameter at 112 Days [ Time Frame: 112 days ] [ Designated as safety issue: No ]
    The colorful complex formed by Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 112 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).


Secondary Outcome Measures:
  • ECMAP in m. Frontialis [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).

  • ECMAP in m. Frontialis [ Time Frame: 112 days ] [ Designated as safety issue: Yes ]
    The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).


Enrollment: 29
Study Start Date: May 2005
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum toxin type - A
Dysport® compared to Botox®
 Drug: Botulinum Toxin Type A (Dysport®)

Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2,5:1. Both reconstituted in the same volume per point, injected in the forehead determined site.

-Dysport®: 5 units will be injected in the left or right forehead side.

Drug: Botulinum Toxin Type A/Botox®
2 units will be injected in the left or right forehead side.(opposite side of dysport injection)
Drug: Botulinum Toxin Type A/Dysport®

Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site.

-Dysport®: 4 units will be injected in the left or right forehead side, 2:1 ratio Dysport/Botox.

Detailed Description:

This was a monocentric, prospective, randomized and double-blind study. Twenty nine female patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had never undergone previous BoNT-A injections were enrolled. Subjects have received botulinum toxin type-A injections in two forehead sites, Botox 2U and Dysport 5U, both reconstituted in the same volume of 0.02 mL per point. Baseline, twenty-eight and 112 days later, clinical and photographic assessments, Minor´s test, and electromyographic (EMG) evaluations were performed.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Written Informed Consent (Annex 1)
  2. Female
  3. Subjects agreeing to take part in all procedures of the study, including botulinum toxin applications, Minor's test, measurement of Evoked Potentials, photographs, etc.), after being fully informed on the objectives and nature of the investigations
  4. Subjects aged between 18 and 60 years
  5. Subjects presenting with moderate to severe wrinkles on the forehead under maximum voluntary contraction of the m. frontalis

  6. Subjects with positive Minor's test showing sweating on the forehead in standardized conditions described in Annex 2

    *The Minor's Test will be the last inclusion criterion to be evaluated. Only these patients eligible according to the other inclusion criteria will undergo the Minor's Test to evaluate their sweating on the forehead. The cut off point is a positive Minor's Test (Level +1) - only subjects with Minor's Test (Level +1) will be recruited in the study (Annex 2).

  7. Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the products under investigation
  8. Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using an effective contraceptive method;
  9. Availability of the patient throughout the duration of the study (112 days)
  10. Subject agrees not to undergo other cosmetic or dermatological procedures during the study
  11. Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol

Exclusion Criteria:

  1. Pregnant women or women intending to become pregnant in the next 4 months after screening for eligibility
  2. Subjects who are lactating
  3. Subjects having undergone botulinum toxin treatment within the last 6 months
  4. Subjects participating in other clinical trials
  5. Any prior surgery affecting the frontalis and/or orbicularis muscles, prior blepharoplasty or brow lift
  6. Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results
  7. Subjects presenting fronto-parietal alopecia according to the Norwood-Hamilton classification
  8. Subjects with neoplastic, muscular or neurological diseases
  9. Subjects using aminoglycoside and penicillamine antibiotics, quinine and Ca2+ channel blockers
  10. Subjects with inflammation or active infection in the area to be injected
  11. Subjects presenting evident facial asymmetry
  12. Subjects with a history of adverse effects, such as sensitivity to the components of the formula, ptosis or any other adverse effect, which in the investigator's opinion should prevent the patient from participating in the study
  13. Subjects presenting myasthenia gravis, Eaton-Lambert Syndrome and motor neuron diseases
  14. Subjects with coagulation disorders or using anticoagulants
  15. Subjects with known systemic autoimmune diseases
  16. Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol
  17. Any condition that, in the opinion of the investigator, can compromise the evaluation of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989768

Locations
Brazil
Brazilian Center for Studies in Dermatology
Porto Alegre, Rio Grande do Sul, Brazil, 90570 040
Sponsors and Collaborators
Brazilan Center for Studies in Dermatology
Investigators
Principal Investigator: Doris M Hexsel, MD
  More Information

No publications provided

Responsible Party: Doris Hexsel, CBED
ClinicalTrials.gov Identifier: NCT00989768     History of Changes
Other Study ID Numbers: 01-CBED06b
Study First Received: October 5, 2009
Results First Received: October 28, 2009
Last Updated: May 24, 2010
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by Brazilan Center for Studies in Dermatology:
Botulinum toxin type A
field effects
dose-equivalence
anhydrotic action halos

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013